Life Sciences Regulatory Counseling & Compliance

Resources

  

Fraud & Abuse Laws/Regulations 

Eliminating Kickbacks in Recovery Act (18 USC §220)  ›

Federal Anti-Kickback Statute (42 USC §1320a-7b)  ›

Federal Civil False Claims Act (31 USC §3729 et seq.)  ›

Federal Civil Monetary Penalties Statute (42 USC 1320a-7a)  ›

Federal Exclusion Law (42 USC §1320a–7)  ›

Federal Health Care Fraud Law (18 USC §1347)  ›

Federal Stark Law (42 USC §1395nn)  ›

OIG Safe Harbor Regulations  ›

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Industry Codes of Conduct

Federal Sentencing Guidelines  ›

OIG Compliance Program Guidance For Pharmaceutical Manufacturers  ›

OIG Compliance Program Guidance for Clinical Laboratories  ›

OIG Compliance Program Guidance for the Durable Medical Equipment, Prosthetics, Orthotics and Supply Industry  ›

ACCME Standards for Commercial Support  ›

AdvaMed Code of Ethics On Interactions with U.S. Health Care Professionals  ›

American Medical Association (AMA) Code of Medical Ethics  ›

American Society of Clinical Laboratory Science (ASCLS) Code of Ethics  ›

Biotechnology Innovation Organization (BIO) Policies  ›

PhRMA Codes & Guidelines  ›

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Corporate Health Care Compliance Resources

Office of Inspector General (OIG) Advisory Opinions  ›

OIG Compliance Guidance  ›

OIG Corporate Integrity Agreements (CIA)  ›

OIG Self-Disclosure Guidance  ›

OIG Special Fraud Alerts, Bulletins and Other Guidance  ›

OIG Reports & Publications  ›

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Regulatory Compliance

Centers for Medicare & Medicaid Services (CMS) Regulations & Guidance  ›

Food & Drug Administration (FDA) Guidance  ›

FDA Office of Prescription Drug Promotion (OPDP)  ›

FDA Warning Letters  ›

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Drug/Device/Biologics/GPO Transparency & Price Reporting Laws

Federal Physician Payments Sunshine Act Transparency Law

Centers for Medicare & Medicaid Services (CMS) Open Payments   ›

State & Local Marketing, Licensure & Transparency Laws

California  ›

Chicago  ›

Connecticut  ›

DC Pharmaceuticals Detailers License Law  ›

DC Marketing Disclosure Law  ›

Maine  ›

Massachusetts  ›

Minnesota  ›

New Jersey  ›

Nevada  ›

Vermont  ›

State Price Reporting Laws

California  ›

Connecticut  ›

Louisiana  ›

Maine  ›

Nevada  ›

Oregon  ›

Texas  ›

Vermont  ›

Washington  ›

  

HIPAA/Privacy/Cybersecurity

Office of Civil Rights (OCR) HIPAA/Health Information Privacy  ›

OCR HIPAA FAQs  ›

Federal Trade Commission (FTC) Health Breach Notification Rule  ›

AMA HIPAA Breach Notification Rules resources  ›

The Office of the National Coordinator for Health Information Technology (ONC) Health Information Privacy Law and Policy  ›

  

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